FDA's Stance On Online Pharmacies May Go Too Far, Study Says

Each year, millions of Americans don't fill their prescriptions because they can't afford to.

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Originally published on April 7, 2012 8:51 am

The Food and Drug Administration has warned people about the many dangers of buying medications from foreign pharmacies over the Internet. While some sites might offer high-quality medicines, there are plenty that sell bogus and potentially dangerous products.

But a recent economic analysis suggests that while there's good reason for the safety warnings, the FDA's stance on the matter might go too far. Many Americans don't fill their prescriptions because they can't afford to, the study says, and some legitimate foreign pharmacies may offer medicines at prices lower than those of verified U.S. suppliers.

"A blanket warning against any foreign website may deny consumers substantial price savings," states the report from the National Bureau of Economic Research.

Researchers Roger Bate, Ginger Zhe Jin and Aparna Mathur looked at how different online pharmacies compared in terms of drug safety and cost savings. They went to dozens of websites and ordered medications widely used by Americans: Viagra, Celebrex, Lipitor, Nexium and Zoloft.

They obtained 328 drug samples from 41 online pharmacies based in the U.S., Canada, Australia, Europe or Asia. They found the foreign suppliers the same way many consumers do: by doing a search on Google and Yahoo.

Eight of the websites were U.S.-based providers verified by the National Association of Boards of Pharmacy, LegitScript.com, PharmacyChecker.com or the Canadian International Pharmacy Association. Those websites were classified as Tier 1 and sold high-quality, authentic drugs. (The researchers established the drugs' authenticity through detailed, chemical analyses.) Another group — classified as Tier 3 — was made up of unverified, mostly foreign providers that sometimes shipped fake versions of one of the drugs, Viagra.

But there was a middle group of mostly foreign suppliers that had been verified by two agencies — dubbed Tier 2 — that sent drugs that were authentic and cost much less than at Tier 1 pharmacies.

In fact, the Tier 2 drugs were, on average, 52.5 percent cheaper (including shipping and handling) than the Tier 1 medicines. The only exception was Viagra, which was the same in drug safety and price for both groups.

"In the U.S., tens of millions of Americans go without prescribed medication due to cost each year," the study says. "For most uninsured Americans, lower priced drugs from foreign online pharmacies are an attractive option and for many a necessary one."

"In light of this," the researchers asked, "we wonder whether a blanket warning against foreign websites has limited price competition between U.S. and foreign websites, and whether a more open and educational policy could make better use of the existing verification services for consumer savings in authentic drugs."

Plus, as Nancy Shute has reported in Shots, people searching for prescription drugs even on legitimate websites can sometimes fall victim to hackers and scams.

Sidney Wolfe, director of Public Citizen's Health Research Group, tells Shots that despite the study's findings, he has concerns about the safety of the products from foreign pharmacies. When drugmakers develop and sell generic copies of existing brand-name drugs, he says, regulators require them to prove the copies are not only chemically identical but work the same way inside the body — a concept known as bio-equivalence.

If the drugs from foreign websites could be shown to be the same in terms of bio-equivalence as drugs from verified suppliers, he says, "we would strongly support it."